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Catheter Precision, Inc. (NYSE American: VTAK) Reports Q1 2024 Highlights and Operational Performance Report

Catheter Precision, Inc. (NYSE American: VTAK) Reports Q1 2024 Highlights and Operational Performance Report

Catheter Precision, Inc.(紐約證券交易所美國股票代碼:VTAK)報告了2024年第一季度亮點和運營業績報告
Accesswire ·  05/07 06:28

FORT MILL, SC / ACCESSWIRE / May 6, 2024 / Catheter Precision, Inc. (NYSE American:VTAK) a MedTech company pioneering products in the growing field of cardiac electrophysiology, including its VIVO and LockeT product(s), releases Q1 Financials, Operational Report for the quarter ending March 31, 2024.

南卡羅來納州米爾堡/ACCESSWIRE/2024年5月6日/ Catheter Precision, Inc.(紐約證券交易所美國股票代碼:VTAK)是一家醫療科技公司,該公司在不斷增長的心臟電生理學領域開創性產品,包括其VIVO和Locket產品,發佈了截至2024年3月31日的季度第一季度財務運營報告。

Operational highlights of the first quarter and early second quarter 2024 include the following:

2024年第一季度和第二季度初的運營亮點包括以下內容:

  • Submission of LockeT for CE Mark approval, which is expected in Q3 2024.
  • First published data on initial LockeT clinical study of over 100 patients presented at Western Atrial Fibrillation Symposium. Data included:
    • 100% immediate hemostasis.
    • Allows for same day discharge.
    • Effective at wound closure up to 27F which includes cardiac catheters and products such as left atrial appendage devices and leadless pacemakers.
    • Reduction in the need for multiple closure devices.
  • Attendance at the European Heart Rhythm Association (EHRA) conference
  • Attendance at Monaco USA Arrhythmia Conference (MUAC) at which positive interim study data related to VIVO was presented on the accuracy of VIVO when used for ventricular ablation on infarcted hearts by Professor Tarv Dhanjal from University Hospital of Coventry and Warwickshire.
  • First VIVO procedure in Spain at Hospital Universitario Virgen de las Nieves in Granda with Dr. Pablo J. Sanchez Millan.
  • First procedures at CHU de Rennes (University Hospital of Rennes) in Rennes, France. This hospital is one of the world's most prolific centers in terms of number of ventricular ablations performed each year.
  • Presentation of the first cases in Turkey by Professor Cem Karadeniz at the National Arrhythmia Congress Turkiye meeting.
  • Recruitment and onboarding of US sales and clinical support in new US regions to support the national launch of LockeT and continued expansion of VIVO.
  • Announced new Chief Commercial Officer, Marie-Claude Jaques, as of May 1, 2024.
  • 提交 Locket 以獲得 CE 標誌批准,預計將於 2024 年第三季度批准。
  • 首次公佈了在西方心房顫動研討會上發表的對100多名患者的Locket初步臨床研究的數據。數據包括:
    • 100% 立即止血。
    • 允許當天出院。
    • 在高達 27F 的傷口閉合時有效,包括心臟導管和產品,例如左心房附屬裝置和無導線起搏器。
    • 減少了對多個封閉裝置的需求。
  • 出席歐洲心律協會(EHRA)會議
  • 出席摩納哥美國心律失常會議(MUAC),考文垂和沃裏克郡大學醫院的塔夫·丹賈爾教授在會上介紹了與VIVO相關的正面中期研究數據,說明了VIVO在對梗塞心臟進行心室消融時的準確性。
  • 西班牙在格蘭達的聖母大學醫院與巴勃羅·桑切斯·米蘭博士一起進行了首次體外活體手術。
  • 在法國雷恩的CHU de Rennes(雷恩大學醫院)進行了首次手術。就每年進行的心室消融術數量而言,該醫院是世界上最多產的中心之一。
  • 傑姆·卡拉德尼茲教授在土耳其全國心律失常大會上介紹了土耳其的首批病例。
  • 在美國新地區招募和加入美國銷售和臨床支持,以支持Locket的全國發布和VIVO的持續擴張。
  • 宣佈自2024年5月1日起新任首席商務官瑪麗·克勞德·雅克斯。

2024 First Quarter Financial Results are as follows:

2024年第一季度財務業績如下:

  • Total assets at March 31, 2024, were $28 million
  • Total cash on position at March 31, 2024 was $1.5 million, and $0.5 million at May 6, 2024
  • Total revenues for the three months ended March 31, 2024 were $82 thousand
  • Shareholders' equity as of March 31, 2024 was $18.5 million
  • Net loss for the quarter ended March 31, 2024 was ($2.7) million
  • All revenue as of March 31, 2024 resulted from the purchase of VIVO Positioning Patches (VIVO accessory product)
  • 截至2024年3月31日,總資產爲2,800萬美元
  • 截至2024年3月31日,頭寸現金總額爲150萬美元,截至2024年5月6日爲50萬美元
  • 截至2024年3月31日的三個月,總收入爲82,000美元
  • 截至2024年3月31日,股東權益爲1,850萬美元
  • 截至2024年3月31日的季度淨虧損爲(270萬美元)
  • 截至 2024 年 3 月 31 日,所有收入均來自購買 VIVO 定位補丁(VIVO 配件產品)

David Jenkins, acting CEO, commented: "During the first quarter of 2024, we focused on acquiring additional talent for the US to support a formal LockeT launch, and expansion of our VIVO footprint in the US. With initial, positive, clinical data available to the public it is the right time to build upon our already great team and focus on our two unique and differentiated products in the EP market. We continue to seek financing solutions to provide sufficient liquidity to enable us to pursue our business objectives, including both public and private financings."

代理首席執行官大衛·詹金斯評論說:“在2024年第一季度,我們專注於爲美國招聘更多人才,以支持Locket的正式推出以及擴大我們在美國的VIVO足跡。隨着初步的積極臨床數據向公衆公開,現在是時候在我們已經很棒的團隊基礎上再接再厲,專注於我們在EP市場上兩種獨特的差異化產品上。我們將繼續尋求融資解決方案,以提供足夠的流動性,使我們能夠實現業務目標,包括公共和私人融資。”

About VIVO
Catheter Precision's VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE Mark.

關於 VIVO
Catheter Precision的VIVO(查看心室發作)是一種非侵入性的三維成像系統,使醫生能夠在術前識別心室心律失常的起源,從而簡化工作流程並縮短手術時間。VIVO 已獲得美國食品藥品管理局的上市許可,並擁有 CE 標誌。

About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA.

關於 LockET
Catheter Precision 的 Locket 是一種縫合固定裝置,旨在幫助經皮靜脈穿刺後的止血。Locket 是一款在 FDA 註冊的 1 類設備。

About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Reincorporated as Ra Medical Systems, Inc. in Delaware in 2018, the Company changed its name to Catheter Precision, Inc. on August 17, 2023.

關於導管精度
Catheter Precision是一家總部位於美國的創新醫療器械公司,爲市場帶來了改善心律失常治療的新解決方案。它專注於通過與醫生合作並不斷改進其產品,爲電生理學手術開發開創性的技術。該公司於2018年在特拉華州重組爲Ra Medical Systems, Inc.,並於2023年8月17日更名爲Catheter Precision, Inc.

Cautionary Note Regarding Forward-Looking Statements

關於前瞻性陳述的警示說明

This communication contains forward-looking statement. Forward-looking statements can be identified by words such as "believe," "anticipate," "may," "might," "can," "could," "continue," "depends," "expect," "expand," "forecast," "intend," "predict," "plan," "rely," "should," "will," "may," "seek," or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, but are not limited to, the following: our belief that it is the right time to build upon our already great team and focus on our two unique and differentiated products in the EP market, and our statement that we continue to seek financing solutions to provide sufficient liquidity to enable us to pursue our business objectives. The Company's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption "Risk Factors" in the Company's Form 10-K filed with the SEC and available at www.sec.gov. These risks and uncertainties include, but aren't limited to, that we do not have sufficient liquidity to fund our operations through May 2024 unless we are able to obtain additional financing or enter into a strategic transaction that would provide additional liquidity, we will not be able to reach profitability unless we are able to achieve our product expansion and growth goals, our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators, we have entered into joint marketing agreements with respect to our products, and may enter into additional joint marketing agreements, that will reduce our revenues from product sales, royalty agreements with respect to our LockeT device will reduce any future profits from this product, if we experience significant disruptions in our information technology systems, our business may be adversely affected, litigation and other legal proceedings may adversely affect our business, if we make acquisitions or divestitures, we could encounter difficulties that harm our business, failure to attract and retain sufficient qualified personnel could also impede our growth, failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our common stock, we have determined that our internal controls and disclosure controls were not effective as of December 31, 2023 and March 31, 2024, and as a result, without effective remediation of the material weaknesses that we have identified, we may not be able to accurately report our financial results or prevent fraud, our revenues may depend on our customers' receipt of adequate reimbursement from private insurers and government sponsored healthcare programs, we may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do, our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms, if hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any, our medical device operations are subject to pervasive and continuing FDA regulatory requirements, our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business, changes in trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products, increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results. The risks and uncertainties described above may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty, or other pandemics, supply chain disruptions from the Ukraine war or Israeli-Hamas conflict and otherwise, and ongoing volatility in the stock markets and the U.S. economy in general.

本通訊包含前瞻性陳述。前瞻性陳述可以通過諸如 “相信”、“預測”、“可能”、“可能”、“可以”、“繼續”、“取決於”、“期望”、“擴展”、“預測”、“打算”、“預測”、“計劃”、“依靠”、“應該”、“可能”、“尋求” 等詞語來識別,或者這些術語和其他類似表述的否定詞,儘管並非所有前瞻性陳述都包含這些詞語。這些前瞻性陳述受1995年《私人證券訴訟改革法》的安全港條款的約束。本新聞稿中包含的前瞻性陳述包括但不限於以下內容:我們認爲現在是在我們已經很棒的團隊基礎上再接再厲,專注於我們在EP市場上兩種獨特的差異化產品的恰當時機;我們聲明我們將繼續尋求融資解決方案,以提供足夠的流動性,使我們能夠實現業務目標。公司對這些問題的期望和信念可能無法實現。由於不確定性、風險和情況變化,實際結果和業績可能與這些前瞻性陳述所設想的結果和業績存在重大差異,包括但不限於公司向美國證券交易委員會提交的10-K表中 “風險因素” 標題下包含的風險和不確定性,可在www.sec.gov上查閱。這些風險和不確定性包括但不限於,除非我們能夠獲得額外的融資或達成提供額外流動性的戰略交易,否則我們沒有足夠的流動性來爲2024年5月的運營提供資金;除非我們能夠實現產品擴張和增長目標,否則我們將無法實現盈利;我們的研發和商業化工作可能取決於與企業合作者的協議;我們已經與之簽訂了聯合營銷協議關於我們的產品,並可能簽訂額外的聯合營銷協議,這將減少我們的產品銷售收入,與我們的Locket設備相關的特許權使用費協議將減少該產品的任何未來利潤,如果我們的信息技術系統出現重大中斷,我們的業務可能會受到不利影響,訴訟和其他法律訴訟可能會對我們的業務產生不利影響,如果我們進行收購或剝離,我們可能會遇到損害我們業務的困難,無法吸引和留住我們的業務足夠的合格的人員也可能阻礙我們的增長,未能維持有效的內部控制可能導致我們的投資者對我們失去信心,並對普通股的市場價格產生不利影響,我們已經確定我們的內部控制和披露控制在2023年12月31日和2024年3月31日沒有生效,因此,如果不有效糾正我們已經發現的重大弱點,我們可能無法準確報告財務業績或防止欺詐,我們的收入可能會取決於我們客戶的收據如果私人保險公司和政府贊助的醫療保健計劃提供充足的報銷,我們可能無法在競爭激烈的行業中成功與公司競爭,其中許多公司的資源比我們多得多,我們未來的經營業績取決於我們能否以商業上合理的條件或根據我們可接受的時間表、價格、質量和數量獲得足夠數量的組件,供應商可能無法交付組件,或者我們可能無法有效管理這些組件,或如果醫院、醫生和患者不接受我們當前和未來的產品,或者任何候選產品獲得批准的適應症市場小於預期,我們可能無法創造可觀的收入,如果有的話,我們的醫療器械業務受美國食品和藥物管理局普遍持續的監管要求的約束,我們的產品在獲得美國食品藥品管理局或外國批准或許可後可能會被進一步召回、撤銷或暫停,這可能會轉移注意力管理和財政資源,損害我們的聲譽,並對我們的業務產生不利影響,美國和其他國家之間貿易政策的變化,特別是徵收新的或更高的關稅,可能會給我們的平均銷售價格帶來壓力,因爲我們的客戶試圖抵消提高關稅、提高關稅或實施其他國際貿易壁壘的影響,可能會對我們的收入和經營業績產生重大不利影響。造成重大經濟不確定性的 COVID-19 疫情或其他流行病、烏克蘭戰爭或以色列-哈馬斯衝突等造成的供應鏈中斷,以及股市和整個美國經濟的持續波動,可能會加劇上述風險和不確定性。

The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

本通訊中包含的前瞻性陳述僅自本文發佈之日起作出。除非法律要求,否則公司不承擔任何義務,也不打算更新這些前瞻性陳述。

CONTACTS:

聯繫人:

At the Company
David Jenkins
973-691-2000
IR@catheterprecision.com

在公司
大衛詹金斯
973-691-2000
IR@catheterprecision.com

SOURCE: Catheter Precision, Inc

來源:Catheter Precision, Inc


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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